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Efficacy of Medical Treatment With SOM230 LAR in Patients With Primary Inoperable Thymoma and/or With Local Recurrent Thymoma to Reduce Tumor Size
Plain-language guide to NCT02021942: phase 2 interventional trial of Pasireotide, 16 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02021942
- Phase
- phase 2
- Status
- completed
- Start
- 2012-03
- Completion (planned or actual)
- 2015-10
- Participants
- 16 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Primary Inoperable Thymoma; Local Recurrent Thymoma
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 2 trial, researchers set out to test Pasireotide.
This is a monocenter, single-arm, open label phase II trial evaluating the effect of SOM230 LAR in adult patients with inoperable primary thymoma and thymoma metastasis (Masaoka II-IVa).
The purpose of this trial is a proof of concept.
It had 1 arm (groups): SOM230 LAR (experimental).
The registry classes the interventions as drug.
Who Took Part
16 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Male or female patients aged ≥18 years. Diagnosis of thymoma as assessed by biopsy and/or szintigraphy. Patients with and without thymoma associated paraneoplastic syndrome. Performance status 0,1, or 2 (ECOG). Patients for whom written informed consent to participate in the study has been obtained.
The full record lists 7 inclusion and 26 exclusion criteria; among the exclusions: patients who are not biochemically euthyroid; patients with symptomatic cholelithiasis; patients with qt related risk factor: qtcf at screening \> 450 msec.
How the Study Was Run
It was run as a single-group and open-label study.
Being open-label, the Pasireotide study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2012-03 with completion listed for 2015-10.
It ran at 1 site in Germany.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Percent Change in Tumor Volume From Baseline to EOS (time frame: at least 6 months).
It also tracked 2 secondary outcomes, for example Tumor Resection Status and Assessment of Tumor Operability.
What This Means in Plain Language
Put simply, this is a phase 2 trial of Pasireotide in 16 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Pasireotide compound page, all human trials.
Our Notes on the Compound
Pasireotide: An FDA-approved multi-receptor somatostatin analog for Cushing's disease and acromegaly; high blood sugar is a common side effect.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.